Objectives: This trial considers whether prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) can improve overall survival as compared with NADT and high-dose prostate and seminal vesicle radiation therapy that is given either as intensity-modulated radiation therapy or as external-beam radiation therapy at either a high-dose rate or with a permanent prostate (radioactive seed) implant boost.
Key entry or exclusion criteria: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration in patients at moderate- to high-risk for recurrence along with clinically negative lymph nodes within 90 days prior and no evidence of bone metastases within 120 days prior.
Locations: 150 sites.
Goal: 2,580 patients.
Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT01368588
NIH clinical trials identifier: NCT01368588